Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001026011
Ethics application status
Approved
Date submitted
19/11/2010
Date registered
23/11/2010
Date last updated
23/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Musculoskeletal Approach for Patients with Symptoms of Pudendal Neuopathy: A Case Series
Scientific title
A Musculoskeletal Approach For Patients Management In Patients with Symptoms of Pudendal Neuropathy: A Case Series
Secondary ID [1] 253145 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pudendal Neuralgia 258685 0
Condition category
Condition code
Musculoskeletal 258829 258829 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(a) 1. Mobilisation Techniques - A manual technique to mobilise/stretch the sacro-iliac joint applied by therapist.
2. Posture Awareness - the patient is instructed how to maintain the correct lumbar curvature posture while sitting at PC, driving etc.
3. Exercise - the patient is instructed by the therapist to perform 5 exercises designed to gain mobility of the sacro-iliac joint and to gain strength of the muscles which control the joint.

b) The intervention is administered until symptoms are reduced (or not). The average number of treatments is four interventions. Generally those will be administered twice a week for as many weeks as necessary.
c) The longest duration of treatment of any particular patient was three months - the minimum was one session. The duration of each intervention session was an hour.
Intervention code [1] 257643 0
Treatment: Other
Intervention code [2] 257644 0
Rehabilitation
Comparator / control treatment
None (Cohort Study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259692 0
Pain Intensity - self reporting with questionnaire
Timepoint [1] 259692 0
Time Point - at end of treatment
- three months after treatment
Secondary outcome [1] 266389 0
Sexual Dysfunction - self reporting questionnair
Timepoint [1] 266389 0
Time Point - At Baseline
- Three months after treatment

Eligibility
Key inclusion criteria
The signs, symptoms and history must fulfill the criteria for the definition of Pudendal Neuralgia
Minimum age
No limit
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Urological diagnosis - such as prostadynia. It means anybody with a urological diagnosis would be excluded. For instance, prostadynia could be aurological diagnosis - but pain in the prostate area could be caused by pudendal neuralgia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/05/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258109 0
Self funded/Unfunded
Name [1] 258109 0
Peter Dornan
Country [1] 258109 0
Australia
Primary sponsor type
Individual
Name
Peter Dornan
Address
13 Morley Street
Toowong QLD 4066
Country
Australia
Secondary sponsor category [1] 257289 0
None
Name [1] 257289 0
Address [1] 257289 0
Country [1] 257289 0
Other collaborator category [1] 251670 0
University
Name [1] 251670 0
University of Queensland
Address [1] 251670 0
St Lucia QLD 4072
Country [1] 251670 0
Australia
Other collaborator category [2] 251671 0
Individual
Name [2] 251671 0
Michel Coppieters
Address [2] 251671 0
University of Queensland
St Lucia QLD 4072
Country [2] 251671 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260092 0
Institutional Ethics Committee
Ethics committee address [1] 260092 0
Institutional Ethics Committee
University of Queensland
St Lucia QLD 4072
Ethics committee country [1] 260092 0
Australia
Date submitted for ethics approval [1] 260092 0
Approval date [1] 260092 0
Ethics approval number [1] 260092 0
2008000007

Summary
Brief summary
Selected patients with signs of pudendal neuralia and low back pain treated with physiotherapy consisting of mobilisation and exercises directed to the lumbar pelvic region.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31934 0
Address 31934 0
Country 31934 0
Phone 31934 0
Fax 31934 0
Email 31934 0
Contact person for public queries
Name 15181 0
Peter Dornan
Address 15181 0
13 Morley Street
Toowong QLD 4066
Brisbane
Country 15181 0
Australia
Phone 15181 0
+61 7 3371 9155
Fax 15181 0
+ 61 7 38710301
Email 15181 0
prdornan@bigpond.com.au
Contact person for scientific queries
Name 6109 0
as above
Address 6109 0
as above
Country 6109 0
Australia
Phone 6109 0
+61 7 33719155
Fax 6109 0
Email 6109 0
prdornan@bigpond.com.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.